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Trial registered on ANZCTR
Registration number
ACTRN12612000650897
Ethics application status
Approved
Date submitted
18/06/2012
Date registered
19/06/2012
Date last updated
24/01/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of corticosteroids versus placebo on sleep quality in patients with advanced cancer
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Scientific title
A double-blind, placebo-controlled cross-over study of the effect of corticosteroids on sleep quality- a pilot study in patients with advanced cancer
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Secondary ID [1]
280199
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None
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Universal Trial Number (UTN)
UTN U1111-1129-1929
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced cancer
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Sleep disturbance
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Condition category
Condition code
Cancer
286328
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0
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Any cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a study of the effects of the timing (i.e. morning versus evening) of administration of dexamethasone on sleep quality. To be eligible, patients will need to already be on any dose of dexamethasone up to 8mg/day. This will delivered over 10 days as 2mg encapsulated tablets (or multiples of) in a daily dose in either the morning or evening as follows:
Treatment Group 1: Day 1-5: dexamethasone in the morning (0800-0900 hr) and matched dose placebo capsule in the evening (1700-1800hr); Day 6-10: placebo in the morning and dexamethasone in the evening.
Treatment Group 2: Day 1-5: placebo in the morning and dexamethasone in the evening; Day 6-10: dexamethasone in the morning and matched dose placebo capsule in the evening.
There will be no 'wash-out' period between changes in the timing of dexamethasone on Days 5-6. The daily dose of dexamethasone will remain unchanged from the dose the patient was taking prior to participation.
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Intervention code [1]
284527
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Treatment: Drugs
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Comparator / control treatment
Both arms in this cross-over trial will act as control as well as intervention arms. Both arms will receive both active and placebo treatments each day; it is the order in which these are received (morning vs evening) that will be manipulated. The placebo will be an inert substance encapsulated to match dexamethasone capsules, delivered once a day in either the morning or evening.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Sleep quality, as assessed by the sleep disturbance sub scale of the Verran and Snyder-Halpern (VSH) sleep scale.
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Assessment method [1]
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Timepoint [1]
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Baseline and daily for 10 days
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Secondary outcome [1]
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Degree of sleep effectiveness (VSH sub scale)
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Assessment method [1]
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Timepoint [1]
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Baseline and daily for 10 days
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Secondary outcome [2]
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Sleep supplementation (VSH sub scale)
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Assessment method [2]
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Timepoint [2]
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Baseline and daily for 10 days
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Secondary outcome [3]
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Use of nocturnal sedation
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Assessment method [3]
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Timepoint [3]
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Baseline and daily for 10 days
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Secondary outcome [4]
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Use of breakthrough medication
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Assessment method [4]
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Timepoint [4]
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Baseline and daily for 10 days
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Eligibility
Key inclusion criteria
-a diagnosis of cancer
-on a stable dose of corticosteroid (CS) for the previous 48hours for any indication
-likely to remain on a stable dose of CS for the next 10 days
-patients on another CS other than dexamethasone must be prepared to convert to an equivalent dose of dexamethasone
- likely to remain on a stable doses of sedatives, hypnotics and analgesics throughout study period.
- likely to remain at home or in hospital (ie in a stable environment) for the duration of the study period
- life expectancy> 1 month
- able to swallow tablets
- ability to understand the patient information sheet, sign a fully informed consent and comply with trial requirements
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
-patients prescribed dexamethasone for emergency management, eg. spinal cord compression, superior vena cava syndrome, raised intracranial pressure (ICP)
-patients being weaned off steroids not willing to remain on a stable dose for 1 0 days
-a history of psychosis
-concurrent medication likely to cause insomnia eg psychostimulants
-uncontrolled diabetes mellitus
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pharmacy will be contacted whenever a patient is under-going the screening process to warn them of a potential trial candidate. This will be followed up by a confirmatory
call as soon as the patient's eligibility has been confirmed. The randomisation request will take the form of the prescription of the study drugs.
The site clinical trials pharmacist will prepare the study drugs for the participant according to the allocation determined by a published 2 arm randomisation schedule
ie whether to start with bottle A or B on the morning of day 1.
They will have previously labelled all dexamethasone capsules as A orB (and all placebo capsules as the other) but will blind the investigators to this allocation.
The allocation will be recorded on the schedule along with the date of allocation, the signature of the pharmacist preparing the drugs and the patient ID number.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated using random permuted blocks
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
22/08/2008
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Actual
22/08/2008
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Date of last participant enrolment
Anticipated
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Actual
12/08/2014
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Date of last data collection
Anticipated
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Actual
26/03/2015
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Sample size
Target
53
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Accrual to date
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Final
3
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment postcode(s) [1]
5151
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4101
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Recruitment postcode(s) [2]
5152
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2065
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Recruitment postcode(s) [3]
5153
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2164
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Recruitment postcode(s) [4]
5154
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2217
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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JP Kelly Mater Research Foundation
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Address [1]
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Mater Health Services Brisbane,
Raymond Terrace,
South Brisbane
QLD 4101
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Mater Misericordiae Health Services Brisbane Ltd
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Address
Raymond Terrace,
South Brisbane
QLD 4101
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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Other Collaborative groups
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Name [1]
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Improving Palliative Care through Clinical Trials (ImPaCCT)
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Address [1]
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Faculty of Nursing, Midwifery & Health, Building 10, Level 7, UTS, 235-253 Jones St, Ultimo, NSW 2007
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Mater Health Services HREC
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Ethics committee address [1]
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Raymond Terrace
South Brisbane
QLD 4101
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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01/08/2008
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Ethics approval number [1]
286957
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1193A
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Ethics committee name [2]
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Cancer Institute NSW
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Ethics committee address [2]
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Cancer Institute NSW
Australian Technology Park
Level 9, 8 Central Avenue
Eveleigh, NSW 2015
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
286958
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Approval date [2]
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03/08/2011
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Ethics approval number [2]
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2011C/06/163
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Ethics committee name [3]
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St Vincent's Hospital Sydney
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Ethics committee address [3]
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390 Victoria St, Darlinghurst NSW 2010
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
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03/08/2013
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Approval date [3]
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08/10/2013
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Ethics approval number [3]
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HREC/13/SVH/241
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Summary
Brief summary
This is a study of the effects of a corticosteroid (dexamethasone) on sleep quality in patients with advanced cancer.
Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of cancer. You should be on a stable dose of corticosteroid for the previous 48 hours for any indication, and likely to remain on a stable dose of corticosteroids for the next 10 days.
Trial details
Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take their usual dose of dexamethasone in the morning and a placebo (sham tablet) at night for five days, and then switch the order for the next five days (i.e. placebo in the morning and dexamethasone at night). Participants in the other group will complete this treatment in reverse order. Only the pharmacist will know which drugs are being taken when.
Participants will be asked to complete a sleep questionnaire each morning in order to assess the effect of the timing of dexamethasone on sleep quality.
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Trial website
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Trial related presentations / publications
none
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Public notes
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Contacts
Principal investigator
Name
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Prof Janet Hardy
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Address
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Department of Palliative and Supportive Care, Mater Health Services, Division of Cancer Services, Level 10 Mater Adult Hospital, Raymond Terrace, South Brisbane, QLD 4101
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Country
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Australia
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Phone
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+61 7 3163 3884
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Fax
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+61 7 3163 8856
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Angela Tapuni
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Address
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Department of Palliative and Supportive Care, Mater Health Services, Division of Cancer Services, Level 10 Mater Adult Hospital, Raymond Terrace, South Brisbane, QLD 4101
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Country
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Australia
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Phone
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+61 7 3163 3884
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Fax
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+61 7 3163 8856
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Angela Tapuni
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Address
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Department of Palliative and Supportive Care, Mater Health Services, Division of Cancer Services, Level 10 Mater Adult Hospital, Raymond Terrace, South Brisbane, QLD 4101
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Country
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Australia
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Phone
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+61 7 3163 3884
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Fax
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+61 7 3163 8856
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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